22 Sep Eisai / Mild Cognitive Impairment or Mild Alzheimer’s Disease…Complete

What is Mild Cognitive Impairment (MCI)?

Mild Cognitive Impairment is a condition in which a person has memory loss or thinking problems that are worse than those caused by normal aging, but not bad enough to interfere with daily activities.  A person with MCI has a higher risk of developing Alzheimer’s disease, though some people with MCI never develop Alzheimer’s disease.

Signs of MCI include:

• Having daily problems with thinking and /or memory
• Trouble remembering appointments
• Losing interest in hobbies or activities
• Repeating questions or stories over and over again
• Having more “senior moments” than you used to
• Forgetting the details of conversations

Early detection of Alzheimer’s disease and MCI is very important so that patients can seek treatment sooner.  Scientists around the world are working to better understand what causes MCI and Alzheimer’s disease and how they affect the brain.  One important piece of the scientific puzzle is clinical research of new investigational drugs.

What is the purpose of the BAN2401-G000-201 Study?

The BAN2401-G000-201 study will test the safety and effectiveness of an investigational drug against placebo (a substance that looks like the study drug but does not contain the active ingredient) in patients with memory loss or increased forgetfulness caused by mild cognitive impairment or mild Alzheimer’s disease.

What is the Study Drug?

The investigational drug being studied is known as BAN2401.  It is being developed to determine if it can prevent the accumulation of beta-amyloid protein in the brain, which is thought to be the main cause of Alzheimer’s disease.  By removing this protein, researchers think that BAN2401 has the potential to slow the progress of Mild Cognitive Impairment and  Alzheimer’s disease.  It has not been approved by the US Food and Drug Administration (FDA) or any other regulatory authority.

Participants will be randomly assigned (by chance) to one of 5 different doses of the study drug, or placebo (a substance that looks like the investigational drug but contains no active ingredient).

Neither you nor the study staff will know what study drug you are receiving.  If there is an important medical reason, the study doctor can quickly identify what study drug is being given.

How will the study drug be administered?

The study drug will be administered in the form of an intravenous (IV) infusion once every 2 weeks.  The procedure takes about 60 minutes each time you visit the study clinic.   Some visits involve other procedures and questionnaires as well.

Who can participate?

Up to 800 people will take part in this study.  In order to determine if this study might be right for you, the study staff will discuss your medical history and current medical condition with you and your study partner.  Some of the basic criteria require that you:

Are 50-90 years of age, and generally healthy

Have memory loss or thinking problems caused by mild cognitive Impairment or mild Alzheimer’s disease

Have a reliable study partner- someone who has regular contact with you ( 8 hours per week) and is able to attend some of the study visits with you—such as a family member or a close friend.

Will I have to pay for the study drug?

No. The study drug, related office visits and all tests and procedures that are required by the protocol are provided to participants at no cost.  No insurance is necessary.

Call (561) 282-5546  or e-mail Lisa for more information or to see if you qualify.